Submissions

Submissions is a regulatory submission management and publishing solution from ArisGlobal, part of the LifeSphere platform. It is designed for life sciences companies, CROs, and regulatory teams that need to create, compile, and publish regulatory submissions across multiple formats and markets within a single unified workflow.

The solution consolidates submissions and publishing into one end-to-end process, starting from a global submission package and supporting automated compilation of national submissions. It is intended to reduce rework by enabling teams to build reusable submission templates and store regulatory knowledge that can be applied across different regions and teams.

Core Capabilities

• Built-in workflows for creating, compiling, and publishing submissions from a global submission package through to national submissions.
• Publishing support for multiple formats, including eCTD, NeeS, PDF, and XML, in compliance with health authority requirements.
• Electronic and paper publishing options to meet national and regional regulatory requirements.
• Dossier record management to maintain the current registered dossier position and its full version history.
• Regulatory knowledgebase for storing and managing national and regional submission requirements.
• Submission reuse functionality that allows global submissions to serve as the basis for national submissions.
• Document propagation to move documents from global to local submission dossiers.
• Assisted compilation of submissions into predefined submission outlines through submission automation.

Workflow and Efficiency Features

• Unified submissions and publishing features integrated within the broader end-to-end RIM workflow.
• Submission templates and regulatory knowledge can be built once and reused across different teams and regions, reducing duplication of effort.
• Global submission packages serve as the starting point for compiling country-specific national submissions, supporting consistency across markets.

Submissions is part of ArisGlobal's LifeSphere platform, which also covers pharmacovigilance and other regulatory functions. ArisGlobal works with more than 220 global life sciences companies, CROs, and government health authorities, including regulatory bodies such as the FDA, Health Canada, and NMPA. The company is headquartered in the United States with regional offices in Europe, India, Japan, and China.